NDC 76125-918
BIVIGAM
Human Immunoglobulin G
BIVIGAM is a Intravenous Injection, Solution in the Plasma Derivative category. It is labeled and distributed by Kedrion Biopharma, Inc.. The primary component is Human Immunoglobulin G.
| Product ID | 76125-918_f2d0d740-6f43-454c-9898-627be94f18e8 |
| NDC | 76125-918 |
| Product Type | Plasma Derivative |
| Proprietary Name | BIVIGAM |
| Generic Name | Human Immunoglobulin G |
| Dosage Form | Injection, Solution |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2013-02-04 |
| Marketing Category | BLA / BLA |
| Application Number | BLA125389 |
| Labeler Name | KEDRION BIOPHARMA, INC. |
| Substance Name | HUMAN IMMUNOGLOBULIN G |
| Active Ingredient Strength | 1 g/10mL |
| Pharm Classes | Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [CS] |
| NDC Exclude Flag | E |
| Listing Certified Through | 2018-12-31 |
Packaging
NDC 76125-918-09
1 VIAL, GLASS in 1 CARTON (76125-918-09) > 100 mL in 1 VIAL, GLASS (76125-918-10)
| Marketing Start Date | 2013-02-04 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 76125-918-09 [76125091809]
BIVIGAM INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA125389 |
| Product Type | PLASMA DERIVATIVE |
| Marketing Start Date | 2013-02-04 |
| Inactivation Date | 2020-01-31 |
NDC 76125-918-04 [76125091804]
BIVIGAM INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA125389 |
| Product Type | PLASMA DERIVATIVE |
| Marketing Start Date | 2013-02-04 |
| Inactivation Date | 2020-01-31 |
NDC 76125-918-10 [76125091810]
BIVIGAM INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA125389 |
| Product Type | PLASMA DERIVATIVE |
| Marketing Start Date | 2013-02-04 |
NDC 76125-918-05 [76125091805]
BIVIGAM INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA125389 |
| Product Type | PLASMA DERIVATIVE |
| Marketing Start Date | 2013-02-04 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| HUMAN IMMUNOGLOBULIN G | 1 g/10mL |
Pharmacological Class
- Human Immunoglobulin G [EPC]
- Passively Acquired Immunity [PE]
- Antigen Neutralization [MoA]
- Immunoglobulins [CS]
NDC Crossover Matching brand name "BIVIGAM" or generic name "Human Immunoglobulin G"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 76125-918 | BIVIGAM | BIVIGAM |
| 59730-6503 | BIVIGAM | BIVIGAM |
| 59730-6502 | BIVIGAM | BIVIGAM |
| 69800-6503 | BIVIGAM | BIVIGAM |
| 69800-6502 | BIVIGAM | BIVIGAM |
| 44206-417 | Carimune | HUMAN IMMUNOGLOBULIN G |
| 44206-418 | Carimune | HUMAN IMMUNOGLOBULIN G |
| 44206-451 | Hizentra | HUMAN IMMUNOGLOBULIN G |
| 44206-452 | Hizentra | HUMAN IMMUNOGLOBULIN G |
| 44206-454 | Hizentra | HUMAN IMMUNOGLOBULIN G |
| 44206-455 | Hizentra | HUMAN IMMUNOGLOBULIN G |
| 44206-456 | Hizentra | HUMAN IMMUNOGLOBULIN G |
| 44206-436 | Privigen | Human Immunoglobulin G |
| 44206-437 | Privigen | Human Immunoglobulin G |
| 44206-438 | Privigen | Human Immunoglobulin G |
| 44206-439 | Privigen | Human Immunoglobulin G |
Trademark Results [BIVIGAM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIVIGAM 85533081 4318477 Live/Registered |
ADMA BIOMANUFACTURING, LLC 2012-02-03 |
 BIVIGAM 77749249 not registered Dead/Abandoned |
Biotest Pharmaceuticals Corporation 2009-06-01 |
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